ECO SPF30 SUN STICK (SPF30 BROAD SPECTRUM SUN STICK) STICK [TROPICAL ENTERPRISES INTERNATIONAL, INC]

ECO SPF30 SUN STICK (SPF30 BROAD SPECTRUM SUN STICK) STICK [TROPICAL ENTERPRISES INTERNATIONAL, INC]
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NDC 58418-274-05
Set ID 747354f2-ee2c-1279-e053-2a91aa0aa707
Category HUMAN OTC DRUG LABEL
Packager Tropical Enterprises International, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Avobenzone (1%)

    Octinoxate (7.5%)

    Octisalate (5%)

    Oxybenzone (4%)

  • PURPOSE

    Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Cirections), decreases the risk of skin cancer and early skin aging caused by the sun.
  • WARNINGS

    Warnings

    For external use only.

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product, keep out of eyes. Rinse with water to remove.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INSTRUCTIONS FOR USE

    Directions

    • apply liberally 15 minutes before sun exposure.
    • reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
      • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeved shirts; pants, hats and sunglasses
      • children under 6 months: Ask a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    *Aloe Barbadenis (Aloe Vera) Leaf Oil, *Cera Flava (Beeswax), *Calendula Officinalis (Calendula) Flower Extract, *Cocos Nucifera (Cocounut) Oil, "Hellanthus Annuus (Sunflower) Seed Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract, *Theeobroma Cacao (Cocoa) Seed Butter, Mixed Tocopherols (Vitamin E).

    *Organic Ingredients

  • OTHER SAFETY INFORMATION

    Other Information

    Protect this product from excessive heat and direct sunlight.

  • QUESTIONS

    Questions or Comments?

    Call 1.866.326.5477

  • PRINCIPAL DISPLAY PANEL

    SPF30BSSUNSTICK

  • INGREDIENTS AND APPEARANCE
    ECO SPF30 SUN STICK 
    spf30 broad spectrum sun stick stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-274
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    APIS CERANA WORKER SECRETION (UNII: PRG8653U8K)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-274-0515 mL in 1 CANISTER; Type 0: Not a Combination Product08/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2014
    Labeler - Tropical Enterprises International, Inc (091986179)
    Registrant - Tropical Enterprises International, Inc. (091986179)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Enterprises International, Inc.091986179label(58418-274)

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